Label: ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release
- NDC Code(s): 63629-8979-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 71406-128
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 16, 2023
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- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- Aspirin Drug Facts
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- STOP USE
- DOSAGE & ADMINISTRATION
- WARNINGS
- SPL UNCLASSIFIED SECTION
- OTHER SAFETY INFORMATION
- INDICATIONS & USAGE
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN 81 MG
aspirin enteric coated tablets 81 mg tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-8979(NDC:71406-128) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW) (UNII: XRK36F13ZZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM BICARBONATE (UNII: 8MDF5V39QO) TALC (UNII: 7SEV7J4R1U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code S17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-8979-1 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 05/03/2021 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-8979) , RELABEL(63629-8979)
